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Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction (CARDIAC)

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

cell therapy, bone marrow derived stem cell

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring bone marrow, cell transplantation, stem cells, PTCA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
single left anterior descending coronary artery disease
<72 hour from the origin of symptoms
successful primary angioplasty of the culprit lesion

Exclusion Criteria:

screening >72 hours after infarction,
cardiac shock, severe comorbidity, alcohol or drug dependency
severe comorbidity (DM,renal or liver insufficiency)
potential child bearing woman
inability to provide informed consent

Sites / Locations

G da Saliceto HospitalRecruiting

Outcomes

Primary Outcome Measures

Mortality

Mortality and Morbidity

Left ventricular function

Secondary Outcome Measures

Left ventricular remodeling

Heart rate variability

Baroreflex sensitivity

Stress induced myocardial ischemia

Cell dose response

Full Information

NCT ID

NCT00437710

First Posted

February 20, 2007

Last Updated

March 23, 2010

Sponsor

Azienda Unità Sanitaria Locale di Piacenza

1. Study Identification

Unique Protocol Identification Number

NCT00437710

Brief Title

Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction

Acronym

CARDIAC

Official Title

Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Azienda Unità Sanitaria Locale di Piacenza

4. Oversight

5. Study Description

Brief Summary

We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy. After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After

Detailed Description

Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

bone marrow, cell transplantation, stem cells, PTCA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

cell therapy, bone marrow derived stem cell

Primary Outcome Measure Information:

Title

Mortality

Title

Mortality and Morbidity

Title

Left ventricular function

Secondary Outcome Measure Information:

Title

Left ventricular remodeling

Title

Heart rate variability

Title

Baroreflex sensitivity

Title

Stress induced myocardial ischemia

Title

Cell dose response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Recent acute transmural anterior myocardial infarction, (in agreement with WHO) single left anterior descending coronary artery disease <72 hour from the origin of symptoms successful primary angioplasty of the culprit lesion Exclusion Criteria: screening >72 hours after infarction, cardiac shock, severe comorbidity, alcohol or drug dependency severe comorbidity (DM,renal or liver insufficiency) potential child bearing woman inability to provide informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Massimo Piepoli, MD, PhD

Phone

+390 523 303217

m.piepoli@ausl.pc.it

First Name & Middle Initial & Last Name or Official Title & Degree

Daniele Vallisa, MD

Phone

+390 523 303737

d.vallisa@ausl.pc.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massimo Piepoli, MD, PhD

Organizational Affiliation

G. da Saliceto Hospital, Regional Health Authority

Official's Role

Principal Investigator

Facility Information:

Facility Name

G da Saliceto Hospital

City

Piacenza

ZIP/Postal Code

29100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Massimo Piepoli, MD

Phone

+390 523 303217

m.piepoli@ausl.pc.it

First Name & Middle Initial & Last Name & Degree

Daniele Vallisa, MD

Phone

+390 523 303737

d.vallisa@ausl.pc.it

First Name & Middle Initial & Last Name & Degree

Massimo Piepoli, MD, PhD

12. IPD Sharing Statement

Links:

URL

http://www.ausl.pc.it/

Description

Azienda USL Piacenza web site

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Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction

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